Crohn's Disease Clinical Trial
Official title:
A Phase 2, Open-label Study to Explore the Pharmacodynamic and Clinical Effects of Mongersen (GED-0301) in Subjects With Active Crohn's Disease
This study is designed to explore mechanism of action of mongersen (GED-0301) 160 mg once daily in patients with active Crohn's Disease
Subjects will be screened to provide 20 enrolled subjects who complete 12 weeks of mongersen
(GED-0301) 160 mg QD treatment as open-label therapy.
The study will consist of 4 periods:
- Screening Period - up to 4 weeks
- Induction Period - 12 weeks (Week 0 Visit through Week 12 Visit)
- Maintenance Period - 88 weeks (after Week 12 Visit through Week 100 Visit)
- Follow-up Period - 4 weeks (ie, no IP taken)
Subjects who prematurely discontinue treatment from this study prior to Week 100 will have an
Early Termination Visit and also enter the 4-week Follow-up Period.
At the Screening Visit, all subjects who meet the entrance criteria will be eligible to enter
the study. The number of subjects with previous exposure to Tumor Necrosis Factor-Alpha
(TNF-α) blockers is targeted to be approximately 40% (ie, approximately 8 subjects).
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